• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORING GROUP SORIN HEATER COOLER SYSTEM 3T

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORING GROUP SORIN HEATER COOLER SYSTEM 3T Back to Search Results
Catalog Number 16-02-82
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Bacterial Infection (1735)
Event Date 11/09/2016
Event Type  Malfunction  
Event Description

Pt underwent cardiac surgery cabgx3 on (b)(6) 2015 and developed mediastinal abscess and was taken to surgery on (b)(6) 2016 to remove wires and abscess. Culture done showed m chimaera in chest wound. Pt had the sorin heater device used during cardiac surgery done on (b)(6) 2015 for 92 minutes.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSORIN HEATER COOLER SYSTEM 3T
Type of DeviceHEATER COOLER SYSTEM 3T
Manufacturer (Section D)
SORING GROUP
lundberg
deutschland
muchen 80939 DE
GM 80939 DE
MDR Report Key6171027
MDR Text Key62275993
Report NumberMW5066656
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2016
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16-02-82
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-